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Post Operative Pain Control: Morphine vs Fentanyl

Primary Purpose

Post Operative Analgesia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Morphine
Fentanyl
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Analgesia focused on measuring post operative analgesia, morphine, fentanyl

Eligibility Criteria

35 Years - 59 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA 1 or 2 patients
  • undergoing major gynaecological surgery

Exclusion Criteria:

  • age > 60 years
  • obesity (BMI>30 Kg/m2)
  • cardiac and respiratory diseases
  • renal impairment
  • liver disorders
  • allergies to any drug used in the study

Sites / Locations

  • catholic University of the sacred Heart

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Morphine

Fentanyl

Arm Description

Patients received morphine 0.02 mg/Kg/h infused at 2 ml/h for 24 hours. The infusion contained morphine and saline.

Patients received Fentanyl 0.3 mcg/Kg/h infused at 2 ml/h for 24 hours. The infusion contained morphine and saline.

Outcomes

Primary Outcome Measures

pain scores
data were recorded at 1,6,18 and 24 hours after surgery

Secondary Outcome Measures

analgesic requirements
if VAS value was equal or higher than 6 patients received ketorolac 30 mg iv

Full Information

First Posted
January 10, 2013
Last Updated
May 21, 2014
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT02146638
Brief Title
Post Operative Pain Control: Morphine vs Fentanyl
Official Title
Post Operative Pain Control: Continuous Infusion of Morphine vs Fentanyl. Clinical Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim of this study is to compare benefits and disadvantages in using continuous infusion of morphine or fentanyl for post operative analgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Analgesia
Keywords
post operative analgesia, morphine, fentanyl

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Patients received morphine 0.02 mg/Kg/h infused at 2 ml/h for 24 hours. The infusion contained morphine and saline.
Arm Title
Fentanyl
Arm Type
Experimental
Arm Description
Patients received Fentanyl 0.3 mcg/Kg/h infused at 2 ml/h for 24 hours. The infusion contained morphine and saline.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Fentanest
Primary Outcome Measure Information:
Title
pain scores
Description
data were recorded at 1,6,18 and 24 hours after surgery
Time Frame
data were recorded during the 24 post operative hours
Secondary Outcome Measure Information:
Title
analgesic requirements
Description
if VAS value was equal or higher than 6 patients received ketorolac 30 mg iv
Time Frame
during the 24 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA 1 or 2 patients undergoing major gynaecological surgery Exclusion Criteria: age > 60 years obesity (BMI>30 Kg/m2) cardiac and respiratory diseases renal impairment liver disorders allergies to any drug used in the study
Facility Information:
Facility Name
catholic University of the sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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Post Operative Pain Control: Morphine vs Fentanyl

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